Human tissue legislation in the United Kingdom 1952- 2006: a history and comparative analysis of policy development

Abstract

This is a study of the genesis of the Corneal (Grafting) Act 1952, the Human Tissue Act 1961, the Human Tissue Act 2004, and the Human Tissue (Scotland) Act 2006. The aim has been to understand why so much had apparently changed between 1952-61 and 2004-06, both in society and in medical practice, as an explanation of why the earlier Acts were essentially ‘enabling/permissive’, whereas the later Acts were ‘regulatory/restraining’. A comparison between the Human Tissue Act 2004 and the separate Human Tissue (Scotland) Act 2006 (both Acts concerned with ‘human tissue’ and with origins in ‘retention of organs without consent’, but with significant differences in their respective provisions), has allowed a finer dissection and comparative analysis of the possible factors involved. The Thesis focuses on the ‘inspiration’, ‘deliberation/ formulation’ and ‘legitimation’ phases of the legislative process (using the terminology of Drewry)-that is, the genesis of the various Acts- and has not sought to study the later (Drewry) phases of ‘implementation’ of the law nor subsequent ‘feedback’. The methodology has been to ‘interrogate the sources’ through in depth study of archived records, using publicly available documents, certain confidential papers made available by the Royal College of Pathologists and the Royal College of Physicians (London), papers released under Freedom of Information Acts, and analysis of the scholarly literature. The findings suggest that a complexity of factors contributed to shaping the 2004 and 2006 legislation, in addition to the proximate ‘organ scandals’. The study may contribute specifically to any wish of Government and the medical/scientific professions to review their processes of consultation and negotiation prior to developing new legislation with an impact on research; and more generally to the case for more regular use of pre-legislative scrutiny of Bills.